# K122254: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Aug 24, 2012 after 28 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922933 (1992). 7 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121229: Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/Cardiotomy, Sorin Group Italia S.R.L. (2012) Summary page 1.

## Most influential descendants
- K130433: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate (2013), 2 descendants of its own
- K201642: Paragon Adult Maxi PMP Oxygenator with Tubing Pack (2020), 1 descendant of its own
- K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs (2025), 0 descendants of its own
- K231414: CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (2023), 0 descendants of its own
- K200683: INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir (2020), 0 descendants of its own

## Indications for use
INSPIRE SM: Hollow Fiber Oxygenator INSPIRE SM is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE SM is intended to be used for 6 hours or less. INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. INSPIRE HVR is intended to be used for 6 hours or less.

Source page: https://510kreport.com/device/K122254
Methodology: https://510kreport.com/methodology